Zydus receives final approval from USFDA for Valsartan Tablets

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") has received final approval from the United States Food and Drug Administration (USFDA) to market Valsartan Tablets USP, 40 mg, 80 mg, 160 mg and 320 mg (USRLD: Diovan® tablets).

Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and paediatric patients one year of age and older. It is also used in adults to treat heart failure (a condition in which the heart is unable to pump enough blood to the rest of the body) and to improve survival after a heart attack.

The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India.

Valsartan tablets had annual sales of USD 149.5 mn in the United States (IQVIA MAT May 2024).

The group now has 400 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 1148.85 as compared to the previous close of Rs. 1154.40. The total number of shares traded during the day was 81609 in over 3512 trades.

The stock hit an intraday high of Rs. 1158.25 and intraday low of 1126.00. The net turnover during the day was Rs. 93706063.00.

(*as of 31st March 2024)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 USFDA FinalApproval ValsartanTablets